Device Classification Name |
orthosis, spinal pedicle fixation
|
510(k) Number |
K132365 |
Device Name |
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION |
Applicant |
ACCEL SPINE |
14901 QUORUM DR. STE. 125 |
DALLAS,
TX
75254
|
|
Applicant Contact |
AEKTA PATEL |
Correspondent |
ACCEL SPINE |
14901 QUORUM DR. STE. 125 |
DALLAS,
TX
75254
|
|
Correspondent Contact |
AEKTA PATEL |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/30/2013 |
Decision Date | 08/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|